Skip to main content

Table 2 Clinical trials of OVs

From: Oncolytic viruses for triple negative breast cancer and beyond

Virus

Disease

Modification

Intervention/treatment

Phase

Number enrolled

dosage-regimen

Primary outcome measure

Secondary outcome measure

Status

NCT number

Adenovirus

Malignant Solid Tumor

Armed with granulocyte-macrophage colony stimulating factor (GMCSF)

CGTG-102

I

12

Intratumoral

intravenous

Safety and tolerability;

Dose Limiting Toxicities (DLT)

Response rate; disease control rate; progression free and overall survival

Completed

NCT01598129

Ovarian Cancer;

Primary peritoneal cancer

E1A gene deletion. RGD motif binds to integrins avb3 and avb5

Ad5-delta24RGD

I

26

Intraperitoneal

Maximum tolerated dose (MTD);

Spectrum of toxicities

Biologic, immunologic and anti-tumor effects of Ad5-delta24RGD

Completed

NCT00562003

Recurrent platinum resistant ovarian cancer

Developed through a process of bio-selection

Enadenotucirev

I

38

Intravenous

Maximum tolerated dose (MTD)

 

Completed

NCT02028117

Pancreatic cancer

Encoding TMZ-CD40L and 4-1BBL(LOAd-703)

LOAd-703;

Gemcitabine;

nab-paclitaxel;

atezolizumab

I/ II

43

Intratumoral

Number of patient with dose-limiting toxicities (DLTs)

Overall Response Rate;

Overall Survival

Recruiting

NCT02705196

Reovirus

Metastatic Breast Cancer

No modification

Paclitaxel Reolysin

II

81

Intravenous

Progression free survival

Response rate; Tumor and tissue response of potential molecular factors; Number of patients with adverse events

Completed

NCT01656538

Herpes Simplex Virus

Solid tumor

A spontaneously attenuated mutant

TBI-1401(HF10)

I

6

Intratumoral

Safety and tolerability

Overall tumor response;

Levels of antibody to HSV-1

Completed

NCT02428036

Brain tumors

Deletion of both copies of the γ1 34.5 gene and a disabling lacZ insertion in UL39 gene (G207)

G207

I

15

Intratumoral

Safety and tolerability

Progression Free Survival;

Overall Survival

Recruiting

NCT03911388

Rhabdomyosarcoma; Osteosarcoma and other

RL1 gene deletion

HSV1716

I

18

Intravenous;

Intratumoral

Safety of intratumoral injection or intravenous infusions

Antiviral immune response

Completed

NCT00931931

Pancreatic cancer

Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor(OH2)

OH2

I/ II

25

Intratumoral

The objective response rate

Safety;

The disease control rate;

The duration of response;

The progression free survival;

Recruiting

NCT04637698

Vaccinia Virus

Advanced solid tumor

Encoding Renilla luciferase-Aequorea green fluorescent protein fusion, β-galactosidase, and β-glucuronidase

GL-ONC1

I

43

Intravenous

Safety and tolerability

Detection of virus delivery to primary and/or metastatic tumors;

Evaluation of anti-vaccinia virus immune response;

Determine recommended dose and schedule for future investigation

Completed

NCT00794131

Hepatocellular Carcinoma (HCC)

Thymidine Kinase deletion;

Arm with GM-CSF

JX-594

II

30

Intratumoral

Proportion of Subjects Achieving Disease Control;

Safety and tolerability;

Number of Subjects Achieving Disease Control;

Median Overall Survival

Completed

NCT00554372

Hepatocellular Carcinoma (HCC)

Thymidine Kinase deletion;

Arm with GM-CSF

Pexastimogene Devacirepvec (Pexa Vec/JX-594) Sorafenib

III

459

Intratumoral

Overall Survival; Overall Response Rate (ORR);

Time to Progression (TTP); Progression Free Survival (PFS); Overall Response Rate (ORR); Disease Control Rate (DCR); Incidence of Adverse Events (AE); Serious Adverse Events (SAE);

Time to Symptomatic Progression (TSP)

Completed

NCT02562755

Measles virus

Ovarian cancer

Expressing carcinoembryonic antigen(MV-CEA)

Encoding thyroidal sodium iodide symporter (MV-NIS)

MV-CEA, MV-NIS

I

37

Intraperitoneally

Dose limiting Toxicity (DLT);

Maximum tolerated dose (MTD)

Number of Responses;

CA-125 levels;

Time to Progression

Completed

NCT00408590